nystatin-a1 and Birth-Weight

Invasive fungal infections are a major cause of morbidity and mortality in preterm infants. The authors conducted the first prospective, randomised controlled trial of nystatin compared with fluconazole for the prevention of fungal colonisation and invasive fungal infection in very low birth weight (VLBW) neonates.. During a 12-month period, all VLBW neonates were assigned randomly to receive nystatin (1 ml suspension, 100 000 U/ml, every 8 h), fluconazole (3 mg/kg body weight, every third day) or placebo from birth until day 30 of life (day 45 for neonates weighing <1000 g at birth). The authors performed weekly surveillance cultures and systemic fungal susceptibility testing.. During the study period, 278 infants (fluconazole group, n=93; nystatin group, n=94; control group, n=91) weighing <1500 g at birth were admitted. There were no differences in birth weight, gestation, gender or risk factors for fungal infection among the groups. Fungal colonisation occurred in 11.7% of the nystatin group and 10.8% of the fluconazole group, as compared with 42.9% of the control group. The incidence of invasive fungal infection was 4.3% in the nystatin group and 3.2% in the fluconazole group, as compared with 16.5% in the control group. There were no differences in fungal colonisation and invasive fungal infection between the nystatin and fluconazole groups.. Prophylactic nystatin and fluconazole reduce the incidence of colonisation and invasive fungal infection in VLBW neonates. The authors believe that nystatin is an alternative to fluconazole, because nystatin is safe, inexpensive, well tolerated and effective.

Topics: Antifungal Agents; Birth Weight; Disease Progression; Drug Resistance, Fungal; Epidemiologic Methods; Female; Fluconazole; Humans; Infant, Newborn; Infant, Premature; Infant, Premature, Diseases; Infant, Very Low Birth Weight; Male; Microbial Sensitivity Tests; Mycoses; Nystatin; Treatment Outcome

Topics: Birth Weight; Candidiasis, Oral; Clinical Trials as Topic; Clotrimazole; Humans; Imidazoles; Infant, Newborn; Infant, Newborn, Diseases; Nystatin; Recurrence

The aim of the study was to investigate the teratogenicity of oral nystatin treatment during pregnancy in the population-based data set of the Hungarian Case-Control Surveillance of Congenital Abnormalities between 1980 and 1996. In total, 38,151 pregnant women who delivered newborn infants without any defects (control group) and 22,843 pregnant women who had foetuses or newborns with congenital abnormalities (CA) (case group) were included in the study. 106 (0.5%) case and 143 (0.4%) control pregnant women were treated with oral nystatin (crude OR with 95% CI = 1.2, 1.0-1.6). A teratogenic potential of nystatin was seen in 1 CA-group (hypospadias) in 2 different approaches of the study (case-control and total control--CA groups comparison) during the critical period of this congenital abnormality. The conclusion of the study is that treatment with oral nystatin during pregnancy presents little teratogenic risk to the foetus, but the possible association between hypospadias and nystatin needs further study.

Topics: Abnormalities, Drug-Induced; Administration, Oral; Adult; Birth Weight; Case-Control Studies; Confidence Intervals; Dose-Response Relationship, Drug; Drug Administration Schedule; Female; Follow-Up Studies; Gestational Age; Humans; Hypospadias; Incidence; Infant, Newborn; Infant, Premature; Male; Nystatin; Odds Ratio; Pregnancy; Pregnancy Complications, Infectious; Pregnancy Outcome; Probability; Reference Values; Registries; Risk Assessment; Teratogens